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WorksheetsInForm for CDM
Total questions: 13
Worksheet time: 10mins
What options are available to close a query?
Query in error
Related query
RSQ
RSQ-NC
When should we use RSQ-NC?
Site confirmed the information and according to guidance and Memo we can close the query
Site provide a valid reason to close the query and performed changes in data base
Site provide a valid reason to close the query and did not perform changes in data base
What phases are there in a study?
Program Planning
Study Start-up
Study Conduct
Study Close-Out
Analysis and Reporting
In which phase is my protocol currently in?
Program Planning
Study Start-up
Study Conduct
Study Close-Out
Analysis and Reporting
When should I do perform the DRC activity?
The specific Data Review activities were completed per DRP
All queries are closed
All queries for the visit are closed
To block and freeze a casebook should I ask for PI signatures 1st?
Yes
No
When should I lock and freeze a casebook?
How frequently should be the DM answered queries review?
Daily
Weekly
Never
Twice a day
How is a Candidate query correctly perform?
Answered query, close query as RSQ-NC, open candidate as DFRU
Answered query, reissue-open, Answered query, closed DRFU, calculate window, open candidate as DFRU
Answered query, calculate window, reissued-candidate query as DRFU
Who is the owner of the prefix MM?
Clinical
Safety
Encoding
DM
When should we use Related query?
When there is a related query of a different role
When there is a related query of DM (manual or autoquery)
When there is another query of any user located in a different place
All above
In general, how long does the site have to enter all the information?
5 days
14 days
1 day
Not specified
Which role performs the DRC activity?
CDM/SCDM
UNB
CRA
PI
